Ireland’s National Institute for Bioprocessing Research and Training (NIBRT) and the Boston Consulting Group (BCG) set up the Biopharma Alliance Innovation Centre in Dublin in January1. The idea is to let biopharma firms explore advanced bioprocessing technologies, according to a NIBRT spokeswoman.

“The NIBRT BCG Alliance was established to show how industry 4.0 technologies could be applied in biopharmaceutical manufacturing to drive efficiencies and increase competitive advantage” she said, adding the facility has already attracted several biopharmaceutical and technologies firm. “Takeda, BMS, Allergan, and MSD were all early adopters who make significant contributions to the Alliance. The Centre now hosts workshops, demonstrations, training and visits from a diverse group of life sciences and related companies.”

Simon Sprague, principal at Boston Consulting Group, added “BCG has a number of Innovation Centres around the world, covering different manufacturing industries and specific parts of the value chain. We find that they are excellent places to learn in, and it is inspiring to see technologies in the flesh and be able to test them in a safe environment. We’re thrilled that our relationship with NIBRT allows us to introduce our many biopharma clients to Industry 4.0 technologies in a hands-on way in an authentic environment, supported by world-class trainers.”

Risk-benefit

Biopharma has been slow to adopt innovative manufacturing technologies, partly because firms are reluctant to spend money modifying facilities. Analysis by Deloitte suggested such considerations slowed the adoption of continuous processing.2 Manufacturing regulations are another factor. NIBRT’s spokeswoman told GEN that cGMP rules make changing processes difficult.

“In accordance with Good Manufacturing Practice (GMP), the biopharmaceutical manufacturing sector is highly regulated to ensure the safety of products manufactured for patients,” she explained. “Therefore, any changes to the manufacturing process are required to have regulatory approval which in some instances can hinder the timelines for deployment of innovative manufacturing technologies.”

“In this context,” added Sprague, “it can also feel like a business risk to stop production to allow for installation of new technologies, without knowing the value which they will deliver ahead of time. A facility such as the Innovation Centre at NIBRT takes out much of that risk, because companies can see the technologies in place and understand the value which they bring. NIBRT is a world-renowned research centre, and companies can also experiment with technologies in a GMP-like environment without putting their business as usual production at risk of interruption” he said.

Integration is a major focus at the facility Sprague says.

“Nearly all of the technologies deployed in the Innovation Centre were designed as part of a detailed blueprint created with four inaugural members of the Biopharma 4.0 Alliance,” he continued. “This blueprint was designed with a strong value focus, so that technologies would be integrated with existing systems, and address specific value opportunities or pain points common in the industry. In this way, the centre is not just a showroom of the latest technologies, you can experience how they can be used both on their own and in conjunction with each other to deliver real value for companies.”

Users can experience a range of simulated manufacturing environments. These include a virtual GMP facility for training on technical operations, GMP behavioral training and a “digital twin” of a factory.

“NIBRT and BCG have partnered with Mersus Technologies,” said the NIBRT spokeswoman. “Creating realistic workplace experiences that mirror real world work scenarios.”

Process developers can also assess what AI—advanced analytics & machine learning and neural networks—can bring to process optimization. There is also a suite dedicated to fill-finish technologies as well as a QC lab and QA centre where users can learn how data mining and visualization can improve process analysis.

References
1. https://www.bcg.com/d/press/29january2020-nibrt-bcg-biopharma-alliance-innovation-centre-237650
2. https://www2.deloitte.com/content/dam/Deloitte/us/Documents/life-sciences-health-care/us-lshc-advanced-biopharmaceutical-manufacturing-white-paper-051515.pdf

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